Medical device antenna systems having external antenna configurations

ABSTRACT

A medical device includes an antenna external to a case, package, or encapsulant for the electronic systems of the medical device. In one embodiment, a diabetes infusion pump is enclosed within a metal case, the pump including a processor and a communication module for wireless communications. An antenna is disposed in the delivery tubing of the pump outside the case with an antenna feed interconnecting the external antenna with the internal communication module. In another aspect, a thin film antenna is formed on the outer surface of the case in which a physiological parameter sensor, such as a glucose sensor, is enclosed. Multiple antennas may be used for communications on different frequencies.

RELATION TO OTHER APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 17/750,500, filed May 23, 2022, which is a continuation of U.S.patent application Ser. No. 16/450,655, filed Jun. 24, 2019, now U.S.Pat. No. 11,369,740, which is a continuation of U.S. patent applicationSer. No. 14/876,185, filed Oct. 6, 2015, now U.S. Pat. No. 10,369,282,which is a continuation of U.S. patent application Ser. No. 12/790,182,filed May 28, 2010, now U.S. Pat. No. 9,184,490, which claims thebenefit of U.S. Provisional Application No. 61/182,678, filed May 29,2009, all of which are incorporated herein by reference in theirentirety for all purposes.

BACKGROUND

The invention relates generally to wireless data transmission and moreparticularly, to antenna systems that are integrated into medicalequipment.

Medical devices often include wireless communication features requiringan antenna associated with each device that transmits or receiveswireless communications. Existing medical devices sometimes includeantenna elements that are located in medical device packages or cases.However, such antennas generally occupy significant areas of therelevant package or the embedded electronics, and may offer sub-optimalperformance due to interference and attenuation associated with thecomponents and packaging within which or with which they are located. Assuch, they are unable to provide reliable wireless communications yetthey significantly increase the overall size of the medical devices.

It is also desirable to make medical devices that must be worn orcarried by a user as small and as light as possible for userconvenience. This has the added benefit of making the medical devicesless intrusive and therefore more likely to be used by the patients.Spreading features among the components can achieve the goal of notmaking any one component large and heavy. Additionally, some medicaldevices may be inherently unfriendly to wireless communications due totheir nature. For example, some diabetes medication pumps have metalcases for durability and to make them water tight. The metal case cansignificantly interfere with wireless communications where the antennais inside the case. It would be desirable to locate an antenna orantennas for wireless communications outside the metal case yet be surethat the antenna is capable of efficiently functioning with the internalcommunications module and circuitry.

In sum, there is a need for an antenna and related systems that mayadequately enable wireless communications between medical devices by,for example, utilizing an external antenna constructed for optimalimplementation with medical device packages.

Hence those skilled in the art have recognized a need for an improvedantenna system that will enable more reliable wireless communicationbetween a medical device and another device. A need has also beenrecognized for antennas that provide a larger radiation pattern with anomni-directional pattern being very desirable. A further need has beenrecognized for maintaining medical devices small while at the same timeallowing them to have reliable wireless communications with otherdevices through the use of efficient antenna structures. The inventionfulfills these needs and others.

SUMMARY OF THE INVENTION

The invention is directed to medical devices having external antennasfor reduced size of the device and more reliable wirelesscommunications. In one aspect there is provided a medical device havingwireless communication capability for data transfer with a host device,the medical device comprising a processor configured to control at leastone function of the medical device, a wireless communication moduleconfigured to communicate at a first frequency, the communication modulebeing in operational data connection with the processor, a caseenclosing the processor and the wireless communication module, the casehaving an outer surface and defining an inside space within which theprocessor and wireless communication module are located, and an outsidespace within which the outside of the case and surrounding areas andobjects are located, the outer surface of the case residing in theoutside space, an antenna located in the outside space configured toefficiently communicate at the first frequency, and an antenna feedinterconnecting the antenna with the wireless communication module,whereby the antenna provides a transducer for wireless datacommunication between the processor and a host device.

In another more detailed aspect, the medical device further comprises apump located in the inside space, the pump being under control of theprocessor, a delivery tube through which the pump forces a medical fluidto flow, the delivery tube having a first end located in the insidespace and a second end located in the outside space, wherein, theantenna feed and antenna are co-located with the delivery tube. Inanother aspect, the antenna feed co-located with the delivery tube iscapacitively coupled to the communication module in the inside space. Inyet another, the antenna feed co-located with the delivery tube isinductively coupled to the communication module in the inside space.

In yet further aspects, the delivery tube comprises a tube wall and alumen through which fluid flows, and the antenna feed and the antennaare formed as part of the tube wall. The delivery tube comprises a tubewall and a lumen through which fluid flows, and the antenna feed and theantenna are formed as part of the tube wall through coextrusion with thedelivery tube. The delivery tube comprises a tube wall and a lumenthrough which fluid flows, and the antenna feed and the antenna areformed as a conductive polymer path embedded and co-extruded within awall of the tube. The delivery tube comprises a tube wall and a lumenthrough which fluid flows, and the antenna feed and the antenna areprinted on an outside surface of the tube. The delivery tube comprises atube wall and a lumen through which fluid flows, and the antenna feedand the antenna include a conductive portion wound around a portion ofthe tube. The delivery tube comprises a tube wall and a first lumenthrough which fluid flows and a second lumen, separate from the firstlumen, and the antenna is located within the second lumen of thedelivery tube.

In other more detailed aspects, the antenna is formed on the outersurface of the case and the antenna feed interconnects the communicationmodule at a point in the inside space to the antenna at a point in theoutside space. The antenna is formed in a meandering pattern.

In yet further aspects, an adhesive patch is attached to the case at onesurface and having a second surface on which is located an adhesivesuitable for holding the patch and the medical device to the skin of auser, wherein the antenna comprises conductive wires woven into a layerof the adhesive patch. The device includes an adhesive patch with afirst side and a second side wherein the antenna is formed on the firstside of the adhesive patch, wherein the case is attached to the firstside of the adhesive patch, and the second side of the adhesive patchcomprises an adhesive surface configured to adhere to skin of a user.

In more aspects, the medical device further comprises a sensor locatedin the inside space, the sensor being operatively connected with theprocessor wherein the case is an encapsulant, wherein the antenna isformed on the outer surface of the encapsulant, and wherein the antennafeed interconnects the communication module at a point in the insidespace to the antenna at a point in the outside space. Additionally, themedical device further comprises a second antenna located in the outsidespace configured to efficiently communicate at a second frequency, and asecond antenna feed interconnecting the second antenna with the wirelesscommunication module.

In yet further aspects, there is provided a medical device havingwireless communication capability for data transfer with a host devicecomprising a processor, a wireless communication module configured tocommunicate at a first frequency, the communication module being inoperational data connection with the processor, a medical devicecomprising a case enclosing communication circuitry and a processor,wherein the communication circuitry and the processor arecommunicatively coupled, a sensor configured to sense a physiologicalparameter and provide sensor data to the processor, a case enclosing theprocessor, the sensor, and the wireless communication module, the casehaving an outer surface and defining an inside space within which theprocessor, sensor, and wireless communication module are located, and anoutside space within which the outside of the case and surrounding areasand objects are located, the outer surface of the case residing in theoutside space, a thin film antenna located in the outside spaceconfigured to efficiently communicate at the first frequency, and anantenna feed interconnecting the antenna with the wireless communicationmodule, whereby the antenna provides a transducer for wireless datacommunication between the processor and a host device.

In more detailed aspects, the thin film antenna is formed on a surfaceof the case. The antenna is printed on an outside surf ace of the tube.The antenna is formed in a meandering pattern. The sensor includes aglucose sensor.

Other features and advantages of the invention will become more apparentfrom the following detailed description of preferred embodiments of theinvention, when taken in conjunction with the accompanying exemplarydrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which constitute a part of thisspecification, illustrate various implementations and aspects of thepresent invention and, together with the description, explain theprinciples of the invention. In the drawings:

FIG. 1 is a block diagram of a medical device having internal functionalmodules and an internal antenna near those modules;

FIG. 2 a shows a diabetes management system in which a delivery deviceattached to a patient's abdomen with an adhesive patch is connectedthrough an infusion set to a delivery site on the patient's abdomen witha handheld control processor in wireless contact with the deliverydevice, the delivery device having an antenna for supporting wirelesscommunication;

FIG. 2 b is an illustration similar to that of FIG. 2 a except that inthis embodiment, the delivery device is located in the pocket of theuser and uses an external antenna disposed about the infusion tubing forwireless communication with the handheld processor;

FIG. 3 a is an end view of tubing used in a diabetes infusion setshowing the inner and outer surface of the tubing wall with electricalconductors fully embedded in the tubing wall and covered by that wallfor use as an antenna;

FIG. 3 b is an end view of an embodiment of infusion set tubing withelectrical conductors partially embedded into the outside surface of thewall of the tubing, the conductors being of use to form an antenna forwireless communications;

FIG. 3 c is also an end view of tubing showing the existence of anelectrical conductor embedded in the wall and forming a part of thatwall of the tubing and being exposed at the outer wall for use as anantenna in supporting wireless communications;

FIG. 3 d is a further end view of tubing used in a diabetes infusion setin which an electrical conductor is partially embedded in the outersurface of the wall of the tubing but is covered by an added layer ofthe tubing;

FIG. 3 e is an end view of tubing used in a diabetes infusion setshowing an electrical conductor placed in a second lumen of the tubingfor use as an antenna to support wireless communications for a deviceusing this tubing;

FIG. 4 a is a side view showing an electrical conductor wrapped aroundthe outer surface of a length of tubing used in a diabetes infusion set,the conductor is wrapped in a helical manner about the tubing and may beused as antenna to support wireless communications for a medical deviceusing the tubing;

FIG. 4 b is also a side view of tubing showing an electrical conductormated to the outer wall of a length of the tubing by means of slots andridges;

FIG. 5 a provides detail of a medication delivery system that includesin this embodiment a medication pump and a diabetes infusion set, withthe pump shown in an exploded view showing a case, a base with internalfunctional devices mounted thereon, and an adhesive mounting patch forlocating the pump on a patient's body;

FIG. 5 b is a partially schematic view of the pump case of FIG. 5 ashowing an antenna feed and antenna extending externally of the case forbetter operation and schematically shown as being terminated within thecase and capacitively coupled to an internal communication component,the capacitive coupling, connection to the communication component, andthe communication component itself being shown in schematic form;

FIG. 5 c is a schematic-type diagram similar to FIG. 5 a in which theelectrically conductive antenna feed is terminated within the case andinductively coupled to the communication component, the inductivecoupling, connection to the communication component, and thecommunication component itself being shown in schematic form;

FIG. 6 shows an exemplary medical device, similar to the pump of FIG. 5a , shown in multiple exploded view, and in particular showing locationsfor mounting antennas in accordance with aspects of the invention;

FIG. 7 a presents an antenna system suitable for use in the medicaldevice of FIG. 6 and others, having a relatively flat configuration;

FIG. 7 b illustrates an exemplary antenna design that is integrated withmedical sensor system components for more efficient wirelesscommunication of sensor data signals and other signals;

FIG. 7 c is a top view of the antenna of FIG. 7 a;

FIG. 7 d presents an antenna and mounting system for mounting theantenna at or near the skin of a patient, showing the various layers formanufacturing purposes, in this case the antenna being fully integratedwith a glucose sensor;

FIG. 8 a is a top view of a medical device, in this case a diabetesmedication pump similar to that of FIG. 6 , showing the positioning ofan external antenna on the adhesive layer; and

FIG. 8 b is also a top view of the medical device of FIG. 8 a showingthe mounting of an external antenna on the upper external surface of thecase rather on the adhesive layer.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Many medical devices, such as sensors and pumps, involve wirelesscommunication. This is particularly true for sensors that measurephysiological parameters such as glucose, and pumps that deliverinsulin, pramlintide, glucagon, or other pharmacological or nutritionalagents. Pumps typically couple to an external infusion set, oftendisposable, that includes an external tube through which fluids arereceived or delivered. The tubing used to deliver or receive the fluidsprovides an excellent opportunity to improve antenna design overconventional antennas that may be used in such medical devices. Asimilar situation can also exist for other medical devices whereexternal antennas may be integrated into an external portion of themedical device, where an external space for mounting an antenna can beprovided, or when the medical device is used with an external componentwhere integration of an antenna is feasible. Such improved antennadesigns may be implemented in a number of ways that provide improvementover existing systems.

In the following description, like reference numerals are used to referto like or corresponding elements in the different figures of thedrawings. Referring now to the drawings with more particularity, FIG. 1illustrates in block diagram format the structure of several existingsystems. FIG. 1 illustrates the basic structure of a medical device 100,which includes functional modules 120 in box form, an internal antenna130 also in box form, and a case 110 surrounding all. Placement of theantenna inside the case 110 increases the size of the case 110, and mayimpair the ability to reliably transmit information in a desireddirection, both because of interference provided by the surrounding case110 and because of the potential for parts of the functional modules 120to be placed between the antenna 130 and a desired radiation direction.Additionally, where the case or packaging 110 is metal, antenna functionmay be severely affected.

FIG. 2 a illustrates use and structure of an embodiment of a system 200consistent with certain aspects related to the present invention. On avery general scale, the system 200 shown in FIG. 2 a comprises aportable handheld wireless electronic device 240, a medical device 210,a connector 230, a user interface device 220, and an antenna 260. Themedical device 210 may be any medical device, such as for the deliveryof medication to a user or for sensing a condition of the user, althoughit may or may not contain a sensor that creates data for transmissionfrom the medical device 210 to the portable handheld electronic device240 using the antenna 260.

Although labeled in general terms as a “user interface device” 220, thisdevice can also take different forms, one of which is an injectioncannula 235, a sensor of a user physiological parameter such as glucose,or other device. The connector 230 may take different forms such as adelivery tubing, or electrical connector.

In this embodiment, the medical device 210, the connector 230 and theuser interface 220 may be thought of as components of a particularmedical system 200 for controllably delivering medication to a user. Theantenna 260 functions with only one component of the system in thisembodiment; i.e., the delivery device 210, but is mounted on anothercomponent (infusion set 240 b) external to the delivery device of thesystem 200, as is discussed in more detail below. The user interfacedevice in this embodiment comprises a medication injection cannula,although other devices may be used for the delivery of medication to theuser at the delivery site, or for sensing a patient physiologicalparameter, or both.

Because the antenna 260 in this embodiment is external to the medicaldevice 210, the “case” or “package” of the medical device 210 can besmaller. Also, the antenna 260 can have a greater size and take avariety of designs than would be possible for an antenna that isentirely confined to the inside of the case of the medical device 210.Such antennas, depending on their wavelength of operation, can berelatively large in comparison to the communication component operatingwith them. Thus, substantial space can be saved by locating themexternally to the transmitter/receiver component with which they areconnected.

In this embodiment, the antenna 260 may be attached to or structured aspart of the infusion set 240 b with which the medical device 210 isoperating, as will be discussed in more detail below. In this case, themedical device 210 is configured in a case to which the infusion set 240b is attached and is an external device, so that the medical device 210is separately located from the injection site of the user.

Separation of the medical device 210 from the injection cannula 235allows for smaller packaging for both, and flexibility in configurationand placement on the body of a user. The length of the medical connector230 (tubing of the infusion set 240 b) also creates a trade off betweenflexibility of placement for the pump 210 and flexibility of placementof the injection cannula 235. When the pump 210 and the injectioncannula 235 are both placed on the body of a user in close proximity,the delivery tubing 230 of the infusion set 240 b may be shorter inlength, with associated lower space and pumping requirements.

The portable handheld electronic device 240 may be any portableelectronic device that includes a processing component, memory forelectronic storage, and a wireless communication system. A wirelesscommunication system (not shown) of the portable electronic device 240may communicate with a communication component or module of the medicaldevice 210 that transmits information using the antenna 260. Accordingto some implementations, the portable handheld electronic device 240 maybe connected to a network that allows upload and download of data to andfrom third party sources such as a user's doctor or a data storage andreporting service. The handheld device can take various forms one ofwhich is envisioned as a smart phone. Of course, any of the antennas 260set forth throughout this disclosure may be used in situations where therecipient device is not a portable handheld electronic device, as thetransmissions can be sent to any stationary processing, orretransmission component configured to receive such signals.

Discussing the embodiment above in more detail, the medical device 210may be an insulin pump for delivering insulin to a diabetic user. Theinsulin pump 210 and the injection cannula 235 of the diabetes infusionset 240 b of FIG. 2 a may each include an adhesive patch 220 that sticksto the skin of a user. This allows both the infusion pump 210 and theinjection cannula 235 to be placed in a large variety of positions onthe body of a user. The infusion set 240 b comprises tubing 230 thatinterfaces between an insulin reservoir (not shown) contained in orattached to the infusion pump 210, to the injection cannula 220 todeliver that insulin internally to the user. The antenna 260 for thissystem that allows communication with the portable electronic device 240is shown figuratively as being part of the tubing 230 of the infusionset 235. A communication component of the infusion pump 210 may beattached to the antenna 260 to transmit insulin delivery data to theportable electronic device 240. The data may then be stored or analyzedat the portable electronic device 240 or conveyed to another location.Additionally, in another embodiment, the handheld electronic device 240may be used to wirelessly communicate programming instructions or otherdata to the pump through the antenna 260.

FIG. 2 b illustrates a system 300 that differs somewhat from that ofFIG. 2 a . However, the system of FIG. 2 b comprises a portableelectronic device 240, a medical device 210, a medical connector 330, anantenna 360, and an injection cannula mounted to the user by an adhesivepatch 220 similar to the system shown in FIG. 2 a . The medical device210 may simply be stored or carried as an attachment or in a pocket ofan article of clothing of the user. In this case, the delivery tubing330 may be significantly longer than the delivery tubing of FIG. 2 asince the pump may not be located as closely to the injection site as inthe system of FIG. 2 a . This allows the pump 210 to be retained in thesame location as the location of the injection cannula 235 is moved oris possibly replaced by interchangeable components of a medical deviceuser interface 220. The antenna 360 of the medical connector 330 in FIG.2 b may only be included in or attached to a portion of the deliverytubing 330 medical connector 330, rather than running the entire lengthof the tubing, depending on the wavelength of operation. In this case,the antenna 360 is wrapped around the outside of the delivery tubing 330in a helical pattern.

FIGS. 3 a through 3 e illustrate various embodiments of antennasintegrated with delivery tubing. All FIGS. 3 a through 3 e show end-on,cross sectional views of medical tubing such as the medical deliverytubing of FIGS. 2 a and 2 b . All tubing of the several views has alumen 390 and a tubing wall 320. The wall has an outer surface 325 andan inner surface 345. Referring first to FIG. 3 a , the tube 331 has alumen 390 for transporting a medical material. The antenna 361 of FIG. 3a is shown as including multiple strips of electrically conductivematerial completely embedded within the tube wall 320, although a singlestrip may be usable in another embodiment. The tubing 332 of FIG. 3 bincludes an antenna 362 made of multiple conductive strips that arepartially embedded or attached to the outside surface 325 of the tubewall 320; however, in another embodiment, a single conductive strip maybe used. In alternate arrangements for both the antenna 361 of FIG. 3 aand the antenna 362 of FIG. 3 b , the antennas may be single stripscovering a small portion of the surface in a cut-out section of the tubewall 320, rather than the multiple strips covering a large portion ofthe outer surface, as shown in FIG. 3 b.

The tube 333 of FIG. 3 c includes an antenna 363 that is part of anentire section of the tube 320 from the outer surface 325 of the wall ornear the outer surface to the inner surface 345 of the wall or near theinner surface, adjacent the lumen 390.

The tube 334 of FIG. 3 d includes an antenna 364 which comprises asingle strip of conductor embedded partially into the outer surface 325of the tube wall 320. The antenna 364 is further covered by anadditional encapsulating layer 340. The encapsulating layer 340 may bemade of the same material as that of the tube 320, and may bemanufactured such that tube 320 and encapsulating layer 340 are acontinuous material, or they may be manufactured separately and asseparate materials.

The tube 335 of FIG. 3 e includes the antenna 365 in a second lumen. Inthis embodiment, the tube has two lumina, the first 390 for deliveringmedical material or fluids, such as insulin, and the second 392 forhousing the antenna 365. In this embodiment, there is a common wallportion 394. Other arrangements may be made for two-lumina tubing; FIG.3 e presents only an example.

In another embodiment (not shown), the tube 335 may have a free-floatingantenna 365 in the same lumen 390 as the medical fluid, wherein theantenna 365 is free floating within the lumen 390. The antenna 365 wouldbe contained within the interior section 390 by the walls of the tube320.

In FIGS. 3 a-3 e , the placement of the shown antenna may extendthroughout a portion or the entire delivery tube. Alternately, differentcross sections of a delivery tube may contain a different profile of theantenna and any encapsulant.

FIGS. 4 a and 4 b show additional implementations where the crosssection of the delivery tube changes over the length of the medicalconnector. FIG. 4 a shows a side view of a delivery tube such as medicalconnector 230 and 330 of FIGS. 2 a and 2 b , and shows a tube 420 withantenna 461. In FIG. 4 a , the antenna 461 is wrapped around the tube420 in a helical coil pattern such that antenna portion 461 a is on theside of the perspective, and the antenna portion 461, shown as thedashed portion, is on the side of the tube 420 away from the perspectiveand behind the tube 420. FIG. 4 b shows a medical connector includingthe tube 420 and an antenna 462. The antenna 462 of FIG. 4 b is ameandering pattern formed completely on the perspective side of the tube420.

Use of the above described antenna configurations with thin film printedantenna or other antenna offer superior radio frequency performance forwirelessly enabled pumps as opposed to internal antenna or single wiretube attached antenna. Use of the above described antenna configurationsmay also provide opportunity for material cost savings related to thinfilm conductors.

FIG. 5 a illustrates a diabetes infusion pump 510 in exploded view, withan infusion set 525 having a length of delivery tubing 560 and aninjection cannula 538 with a mounting adhesive patch 532. The deliverytubing is coupled to the injection cannula through a connector 530having two disconnectable parts. A female portion 536 is releasablysecured to a male portion 534 such that they may be disconnected fromeach other at the user's convenience. The user may wish to disconnectthe connector when he or she is performing an activity where the pumpshould be removed. An example of such an activity is removing theinsulin pump to take a shower.

The pump 510 includes a case 514, the functional modules of the insulinpump 518 including a wireless communication module, and an adhesivepatch 520 attached to a surface of the pump 510 for mounting the pump510 to the skin of a user. The antenna (not shown) is embedded withinthe delivery tubing 560 and may be attached to a communication modulethat is part of the insulin pump 518 at a point at or near where thedelivery tubing attaches; i.e., at antenna interface 570.

As shown purely by way of illustration and example in FIGS. 5 b and 5 c, the various external antennas 560 disclosed throughout may also beconnected to their associated medical device by means of a capacitive orinductive coupling. FIG. 5 b schematically shows details related tocapacitively coupling 580 the antenna 560 to the communications moduleof the medical device 510 of FIG. 5 a . The coupling element 580 is madeup of capacitive plates 580A and 580B. This connection at the antennainterface 570 allows the antenna 560 which is attached to the deliverytubing 540 to deliver signals to and from the pump communication module590 which is included inside the case 514 of the pump 518.

FIG. 5 c shows an alternative means of coupling the antenna 560 to thecommunication circuitry 590. In this illustrative implementation, theantenna interface 570 includes a coupling element 580 which isschematically shown as an inductive coupling element. This couplingelement 580 also allows the antenna 560 which is attached to thedelivery tubing 540 to deliver signals to and from medical devicewireless communication circuitry 590. As shown in this implementation,the coupling element is included inside the case 514 of the insulin pump518.

Although not shown, direct electrical coupling to the antenna feedwithin the case of the medical device may also be performed. The tubingembodiments of FIGS. 3 b and 3 e have metallic antenna feed components362 and 363 exposed at the outer surface of the tubing that would bemated with electrical conductors forming a part of the communicationcomponent inside the case of the medical device 510. A two-point contactconnector can be used to simultaneously connect the fluid connection ofthe tubing and the antenna connection of the tubing within the pump 510.In a case where the infusion set comprises a built-in reservoir and afluid connection is not necessary, the electrical connection would bemade with an appropriate connector within the medical device. Suchtwo-point connectors and other electrical connectors are well known tothose of skill in the art and no further details are provided herein.

FIG. 6 shows a medical device 610 along with an exploded view ofcomponents that comprise medical device 610 in this embodiment. Themedical device 610 is assembled from a pump and base assembly 620, askin patch assembly 630, and a hook fastener 626, and may include a pumpsurface mounted external antenna 660. The pump and base assembly 620 arefurther assembled from a pump 622 with the associated package cover, anda base 624. The skin patch assembly includes a fastener loop 632 with anantenna coupling area 640, a skin adhesive pad 634, and an externalantenna 650. The antenna coupling area 640 may be a physical port, anopening, or a portion of the fastener loop 632, base 624, and/or hookfastener 626 designed to provide access or minimal barrier to an antennacoupling at each layer between the external antenna 650 and anycommunication circuitry inside the medical device 610. The externalantenna 650 may trace the edge of the skin adhesive pad 634 for aportion of the edge, the entire edge with a break to prevent a currentloop, a spiral, or any pattern on the adhesive pad 634 that providessuitable wireless performance. The medical device may include one, two,or more external antennas. The medical device 610 is shown as a devicewith two external antennas having both external antenna 650 and pumpsurface mounted external antenna 660. One may be used at a firstfrequency, such as 2.4 GHz while the other is used as a secondfrequency, such as 433 MHz.

FIG. 7 a illustrates an exemplary external antenna system 700 for usewith medical devices such as an insulin, pramlintide and glucagon pumpsand meters or monitoring devices for materials such as glucose or otherblood or patient content monitors that include a wireless transmissionsystem. The antenna system 700 includes a primary antenna 710, a circuit720, a secondary antenna 730, and a mounting surface 740.

FIG. 7 b shows the primary antenna 710, the circuit 720, and the sensor750. The sensor 750 is coupled to the circuit 720, and may provide datarelated to, for example, glucose levels or levels of another bloodcontent, drug, or analyte testable in a patient to which the sensor 750is attached. The circuit 720 may contain additional circuitry related tosensing the material being monitored, as well as containing an internalantenna and RF communication circuits. The sensor 750 may be attached toan antenna system via a cable, or may be integrated in a single mount740 with the rest of the antenna system 700. The circuit 720 iselectrically connected to the primary antenna 710. The primary antenna710 as shown by way of example in FIGS. 7 a and 7 b may be a single loopsquare antenna. The primary antenna 710 may additionally be a circularsingle loop antenna, a planar spiral antenna, a multi-loop antenna, orany other antenna capable of fulfilling a similar function, and also bemade of any suitable conducting material. For example, the primaryantenna 710 may be made of gold, copper, aluminum, or a printable carbonbased conductor.

FIG. 7 c shows a secondary antenna 730 and a mounting 740. The secondaryantenna 730 is coupled to the circuit 720, either directly or viacoupling with the primary antenna 710. The secondary antenna 730 asshown in FIG. 7 c is a meandering antenna with a loop or pad at one end.The loop in the secondary antenna 730 includes a cut out to preventformation of a current loop that will degrade the radiation power. Theloop operates as a coupling antenna to improve the radiation power ofthe secondary antenna 730. The pad that is part of secondary antenna 730may be used to form a capacitive coupling with a ground plane of therelevant circuit 720, as illustrated by way of example in FIG. 7 b . Thesecondary antenna 730 may also be shaped like with any other arrangementof antenna that fulfill a similar function. Secondary antenna 730 mayalso be made of any appropriate conductive material similar to primaryantenna 710.

The mounting surface 740, shown in FIGS. 7 a and 7 c , provides asupport structure for the secondary antenna 730 as well as the circuit720 and the primary antenna 710. In one implementation, the circuit 720and the primary antenna 710 may be created in or on a first surface ofmounting 740, and the secondary antenna 730 may be created on a secondor opposite surface of the mounting 740. For example, the primaryantenna may be printed on a transmitter circuit board and the secondaryantenna printed on an adhesive patch. In further implementations, thesecondary antenna 730 may be created on a first surface of mounting 740and the circuit 720 and the primary antenna 710 may be created above thesecondary antenna 730 on the same side of the mounting 740 with adielectric layer between the overlapping sections to prevent electricalshorts between the various components.

The mounting 740 may be composed of flexible material to allowconformity with a surface to which the mounting 740 is located, such asa body or a curved casing. If the mounting 740 is flexible, the materialthat makes up the primary antenna 710 and the secondary antenna 730 willeither be sufficiently flexible to avoid cracking or snapping when themounting 730 bends, or will be supported by additional supportstructures to prevent bending that would cause such damage. In onealternative implementation, the primary antenna 710 and the circuit 720are created on an inflexible dielectric which is mounted to a flexiblemounting 740 having a flexible implementation of the secondary antenna730 on one side. The opposite side of the mounting 740 is covered withan adhesive material that allows the mounting 740 to be attached to acurved surface while still connected to a primary antenna 710 and/orother circuitry (i.e., circuit 720), which may be supported, e.g., by aninflexible dielectric element.

FIG. 7 d illustrates the structure of an embodiment consistent withcertain aspects related to the present invention. Referring to FIG. 7 d, a system 760 is shown mounted to the skin 796 of a user. A mounting740 is attached directly to the skin as an adhesive patch layer, and maybe similar to the mounting 740 of FIG. 7 c . The mounting 740 isattached to a bottom surface of a thin film substrate 792 which containsa secondary antenna such as the secondary antenna 730 of FIG. 7 c ,within a printed conductive layer 782. A transmitter adhesive layer 784is attached to the top surface of the printed conductive layer 782, andattaches the encapsulated transmitter 790 to the mounting 740 throughthe other layers. The encapsulated transmitter 790 includes electroniccomponents 788 and a printed circuit board 786. The printed circuitboard 786 may contain a primary antenna such as the primary antenna 710of FIG. 7 a . The sensor tip 752 may be a portion of a sensor such asthe sensor 750 of FIG. 7 a . The sensor tip 752 is inserted into theskin 796 of the user, and is attached to the printed circuit board 786via the sensor either through a via or around the edge of the substrateand mounting layers.

FIG. 8 a illustrates the structure of certain components of anembodiment consistent with certain aspects related to the presentinvention. Referring to FIG. 8 a , a medical device 810 is shown. Themedical device 810 is attached to an adhesive layer 820 that includes anantenna 830. The antenna 830 may be printed on a surface, embeddedwithin a surface, or woven into a woven material layer of the adhesivelayer 820. The antenna 830 may be electrically connected to RFtransmission circuitry contained within the medical device 810 throughan electrical connection contained in the adhesive layer 820. Asdescribed above, the adhesive layer 820 may be used to attach themedical device 810 to a user. Persons of ordinary skill in the art willappreciate that the system is exemplary, and that alternative structuresconsistent with the aspects related to the present invention arepossible. For example, FIG. 8 b illustrates one alternative, wherein theantenna 830 is positioned on the outside case of the medical device 820.The medical device 810 is still attached to an adhesive layer 820 thatmay be used to attach the medical device 810 to a user. The antenna 830may be electrically connected to communication circuitry inside themedical device 810 by an electrical path through the case of the medicaldevice 810.

Use of external packaging such as shown in FIGS. 6 and 8 b, or anadhesive mounting patch such as shown in FIGS. 7 and 8 a with a thinfilm printed antenna or other antenna configurations offer superiorradio frequency performance for wirelessly enabled pumps as opposed tointernal antenna or single wire tube attached antenna.

The embodiments set forth in the above descriptions do not represent allembodiments consistent with the claimed invention. Instead, they aremerely some examples consistent with certain aspects related to theinvention. While only the presently preferred embodiments have beendescribed in detail, as will be apparent to those skilled in the art,modifications and improvements may be made to the device disclosedherein without departing from the scope of the invention. Accordingly,it is not intended that the invention be limited, except as by theappended claims.

The invention claimed is:
 1. A glucose monitoring device configured tobe worn on skin of a user, the glucose monitoring device comprising: amounting portion configured to support a printed circuit board,electronic circuitry, a first antenna, and a second antenna, wherein theelectronic circuitry comprises a processor and a wireless communicationmodule; an adhesive layer configured to attach the mounting portion tothe skin of the user; and a glucose sensor configured to sense a glucoselevel in a bodily fluid of the user, the glucose sensor comprising: aproximal portion configured to be coupled with the electronic circuitry;and a distal portion including a tip portion configured to be positionedunder the skin of the user, wherein the glucose sensor is attached tothe printed circuit board through a via of the mounting portion, whereinthe wireless communication module is configured to communicate dataindicative of the glucose level to a portable handheld electronicdevice, wherein the first antenna and the second antenna areelectrically coupled with the electronic circuitry, wherein the firstantenna comprises a multi-loop antenna, wherein the second antennacomprises a meandering antenna located on a same side of the printedcircuit board as the electronic circuitry, wherein the first antenna isconfigured to wirelessly communicate at a first frequency, and thesecond antenna is configured to wirelessly communicate at a secondfrequency different from the first frequency, wherein at least onedielectric layer of the printed circuit board is disposed between aportion of the first antenna and a portion of the second antenna.
 2. Theglucose monitoring device of claim 1, wherein the wireless communicationmodule comprises radio frequency (RF) communication circuitry coupledwith the second antenna.
 3. The glucose monitoring device of claim 2,wherein the portable handheld electronic device is a smart phone.
 4. Theglucose monitoring device of claim 1, further comprising an enclosedspace, wherein the electronic circuitry, the printed circuit board, andthe proximal portion of the glucose sensor are disposed entirely in theenclosed space.
 5. The glucose monitoring device of claim 1, wherein thesecond antenna is disposed on a first dielectric layer of the printedcircuit board proximal to a second dielectric layer of the printedcircuit board, and wherein at least a portion of the first antenna isdisposed in the second dielectric layer of the printed circuit board. 6.The glucose monitoring device of claim 1, wherein the second antenna isprinted on a surface of the printed circuit board.
 7. The glucosemonitoring device of claim 1, wherein the first frequency or the secondfrequency is 433 MHz.
 8. The glucose monitoring device of claim 1,wherein the first frequency or the second frequency is 2.4 GHz.
 9. Theglucose monitoring device of claim 1, wherein the first antennacomprises a copper material.
 10. The glucose monitoring device of claim1, wherein the first antenna comprises a gold material.
 11. The glucosemonitoring device of claim 1, wherein the first antenna comprises aprintable carbon-based conductor.
 12. The glucose monitoring device ofclaim 1, wherein the second antenna comprises a copper material.
 13. Theglucose monitoring device of claim 1, wherein the second antennacomprises a gold material.
 14. The glucose monitoring device of claim 1,wherein the second antenna comprises a printable carbon-based conductor.15. The glucose monitoring device of claim 1, wherein the mountingportion comprises a flexible material configured to conform with asurface of the skin.
 16. The glucose monitoring device of claim 1,wherein the second antenna includes a pad located at an end portion ofthe second antenna, wherein the pad is coupled with the printed circuitboard.
 17. The glucose monitoring device of claim 1, wherein the secondantenna includes a loop located at an end portion of the second antenna.18. The glucose monitoring device of claim 1, wherein the loop locatedat the end portion of the second antenna includes a cut-out.
 19. Aglucose monitoring device configured to be worn on skin of a user, theglucose monitoring device comprising: a mounting portion configured tosupport a printed circuit board, electronic circuitry, a first antenna,and a second antenna, wherein the electronic circuitry comprises aprocessor and a wireless communication module; an adhesive layerconfigured to attach the mounting portion to the skin of the user; and aglucose sensor configured to sense a glucose level in a bodily fluid ofthe user, the glucose sensor comprising: a proximal portion configuredto be coupled with the electronic circuitry; and a distal portionincluding a tip portion configured to be positioned under the skin ofthe user, wherein the glucose sensor is attached to the printed circuitboard through a via of the mounting portion, wherein the wirelesscommunication module is configured to communicate data indicative of theglucose level to a portable handheld electronic device, wherein thefirst antenna and the second antenna are electrically coupled with theelectronic circuitry, wherein the first antenna comprises a multi-loopantenna, wherein the second antenna comprises a meandering antennalocated on a same side of the printed circuit board as the electroniccircuitry, wherein the first antenna is configured to wirelesslycommunicate at a first frequency, and the second antenna is configuredto wirelessly communicate at a second frequency different from the firstfrequency, wherein the second antenna is disposed on a first dielectriclayer of the printed circuit board proximal to a second dielectric layerof the printed circuit board, and wherein at least a portion of thefirst antenna is disposed in the second dielectric layer of the printedcircuit board.
 20. The glucose monitoring device of claim 19, whereinthe wireless communication module comprises radio frequency (RF)communication circuitry coupled with the second antenna.
 21. The glucosemonitoring device of claim 20, wherein the first frequency or the secondfrequency is 2.4 GHz.
 22. A glucose monitoring device configured to beworn on skin of a user, the glucose monitoring device comprising: amounting portion configured to support a printed circuit board,electronic circuitry, a first antenna, and a second antenna, wherein theelectronic circuitry comprises a processor and a wireless communicationmodule; an adhesive layer configured to attach the mounting portion tothe skin of the user; and a glucose sensor configured to sense a glucoselevel in a bodily fluid of the user, the glucose sensor comprising: aproximal portion configured to be coupled with the electronic circuitry;and a distal portion including a tip portion configured to be positionedunder the skin of the user, wherein the glucose sensor is attached tothe printed circuit board through a via of the mounting portion, whereinthe wireless communication module is configured to communicate dataindicative of the glucose level to a portable handheld electronicdevice, wherein the first antenna and the second antenna areelectrically coupled with the electronic circuitry, wherein the firstantenna comprises a multi-loop antenna that is disposed in at least onelayer of the printed circuit board, wherein the second antenna comprisesa meandering antenna located on a same side of the printed circuit boardas the electronic circuitry, wherein the first antenna is configured towirelessly communicate at a first frequency, and the second antenna isconfigured to wirelessly communicate at a second frequency differentfrom the first frequency, and wherein the portable handheld electronicdevice is a smart phone.
 23. The glucose monitoring device of claim 22,wherein the second antenna is printed on a surface of the printedcircuit board.
 24. The glucose monitoring device of claim 22, whereinthe second antenna is disposed on a first dielectric layer of theprinted circuit board proximal to a second dielectric layer of theprinted circuit board, and wherein at least a portion of the firstantenna is disposed in the second dielectric layer of the printedcircuit board.
 25. The glucose monitoring device of claim 22, whereinthe first frequency or the second frequency is 2.4 GHz.